NCT00140361

Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria

Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children \< 5 years in 3 sites in rural Tanzania. Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

Detailed description

This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children \< 5 years in 3 sites in rural Tanzania. Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

Conditions

• Malaria (Uncomplicated)

Interventions

Type	Name	Description
DRUG	Sulfadoxine-pyrimethamine
DRUG	sulfadoxine-pyrimethamine plus artesunate
DRUG	lumefantrine plus artemether
BEHAVIORAL	Sleeping under insecticide-treated bednet

Timeline

• Start date: 2000-01-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-09-01
• Last updated: 2012-09-11

Locations

3 sites across 1 country: Tanzania